JANITRI

More than 99% of mother and newborn deaths occur in developing countries like India, Africa etc. Around 80% of deliveries happen in low resource healthcare settings which lacks skilled manpower and medical devices. Fetal heart rate and uterine contraction are the importance parameters to monitor the status of both mother and fetus during intrapartum period but monitored inaccurately or ignored more than 85% of the time, hence leads to mortality/morbidity in case of complications. KEYAR is an affordable and super easy to use patch based wearable maternal fetal monitoring device for intrapartum period which also communicates with DAKSH intrapartum monitoring mobile application for the intelligent alerts and remote monitoring. The product is for the staff nurses/midwives/doctors which help them in monitoring the mother and fetus during labor phase. The intelligent alerts also help them in taking early decision which eventually save lives during labor phase.

Every year, an estimated 1.02 million intrapartum stillbirths, 904000 intrapartum neonatal deaths & 250000 maternal deaths occur globally. More than 99% of those deaths occur in developing countries like India and Africa. In India, more than 80% deliveries conducted in low resource healthcare settings which lack of skilled healthcare workers and medical devices. During intrapartum period, fetal heart rate and uterine contraction monitoring is really important to know the status of the mother and fetus, but monitored inaccurately and ignored more than 85% of the time. This leads to mortality/morbidity in case of any anomaly.

Existing device cardiotocography is high cost (>3000 USD), non-portable (5 Kg) and required skilled healthcare worker for continuous monitoring of FHR & uterine contraction displays both the parameters in a graphical format. In current practice, gynaecologist analyzes the pattern of fetal heart rate & uterine contraction on printed CTG graph to recognize the fetus distress. Based on that, they take early decision to prevent any mortality or morbidity.

WHO Partograph is designed to monitor & make timely interventions to prevent complications during the intrapartum period. More than 90% of the midwives fill the partograph after delivery, that too for the data recording formality.

KEYAR is an easy to use patch based fetal heart rate, uterine contraction and maternal heart rate monitoring device for intrapartum period. The patch gets connected to the handheld unit. The handheld unit has an inbuilt processor, circuits, battery and small display to show case the required readings and graphs. It can work as an independent wearable monitoring device. KEYAR uses the electrical signal based technology to pick up the fetal ECG, maternal ECG and uterine EMG and further calculate fetal heart rate, uterine contraction and maternal heart rate. 

 KEYAR can also communicates with DAKSH which is an intrapartum monitoring mobile application for the intelligent alerts, automated WHO partograph generation and remote monitoring. DAKSH has 3 components. One is for the staff nurses/midwives which can be used inside the labor ward. Second one is for the doctor/OBGYNs which can be used to see data anywhere live. Third one is the dashboard/centralized monitor to see the overall data.

During intra-partum period, delay in diagnosis of fetal distress leads to neonatal morbidity & mortality. We have visited more than 100 healthcare settings across India includes primary, secondary & tertiary and discussed with more than 200 staff nurses, 100 doctors and 20 senior gynaecologists. Most of the deliveries conducted by staff nurses in low resources healthcare settings which lacks of continuous labor monitoring devices and skilled staff in maternity ward. In current practices, staff nurses measure the FHR by stethoscope/fetoscope/fetal Doppler and take decision of any intervention/referral in case FHR goes beyond threshold value. They do not consider FHR & uterine contraction together that leads to delay in early detection of fetal distress and further leads to delay in early referral to higher health facility. An affordable & easy to use labor monitoring device for early detection of fetal distress for low resources healthcare settings has a potential to prevent neonatal mortality & morbidity. In low resources healthcare settings where cesarean facility is not available, the early detection of fetal distress will help low skilled health workers in early decision for referral to higher health facility. 

Maternal and neonatal mortality/morbidity is the key challenge in developing countries. More than 99% of maternal and neonatal mortality/morbidity occur in developing countries. In India, more than 70% deliveries conducted in low resource healthcare settings which lack of skilled healthcare workers and medical devices. In India, we have only 45,000 OBGYN over 27 Million births per year. Hence, more than 80% deliveries happen without the assistance of any Doctor/OBGYN. In this scenario, affordable and easy to use innovations which can empower the midwives/staff nurses in assisting delivery/monitoring/referral/early decision making will definitely make impact in reducing the MMR and IMR.

Existing device cardiotocography (available since last 3-4 decades) is high cost (>2000 USD), non-portable (5 Kg) and required skilled healthcare worker to operate the device.

The companies "Monica Healthcare" acquired by GE healthcare, "Nemo Healthcare" are also using the similar technology like ours to solve the problem. However, the whole concept, cost, product and business have been designed considering the developed market.

In India, three other startups “Sattva Medtech” based in Bangalore, “Brun Health” based in Delhi and "CareNX" based in Mumbai who are working on fetal monitoring devices. The device from “Sattva Medtech” designed for the premium hospital market. It cost up to 2000 USD which is similar to the existing CTG cost. It transmit the FHR & contraction signal on mobile application hence it has a dependency. KEYAR shows the output on an inbuilt display and also transmit the FHR and contraction data to mobile application if required. The device from “Brun Health” and "CareNx" uses the doppler and toco technology which required a belt for placement leads to discomfort like CTG. KEYAR is a combination of a patch and wearable device which does not require a belt.

5 Core technologies

ERM (Electronic Record management):
This is an existing technology that companies use to record a particular set of data and retrieve it on the client's demand across the globe.
AI:
The current system collects data through a mobile application and metadata is collected from the actual information. Post collection the system run mathematical equations on the metadata to derive to a possible conclusion with a confidence percentage and accuracy percentage.
IoT:
This is existing technology but a new type of application interface is created to support various devices across the globe. The system is currently designed to support wired and wireless communication. This API can be used to expand the support for other IoT devices, considering we understand how the IoT device network works.
Bio-Logical Signal processing:
This is existing technology which is used for the record the event such as a beating heart or a contracting muscle. System developed processes the ECG and EMG data which is collected from the abdomen of a pregnant lady greater than 36 GA and process data and give the Fetal Heart rate, Maternal Heart Rate, and Uterine Contraction.
Embedded Electronics:
It is Existing technology which is a combination of electronics hardware and software designed for a specific function. In our system, we are using it for the acquire ECG and EMG from the patient and generate the Fetal Heart rate, Maternal Heart rate, and Uterine contraction by using the bio-signal processing technology as well it is transmitting data to the wireless interface.

ERM

Currently, the system has a record of 20k+ patients. The demand for the product has inspired us to work more towards a complete cycle. Initially, the system was designed to support a part of the hospital process. Through the process of user feedback, the product has evolved from a simple patient record management to record the entire intrapartum process and postpartum process of the patient. 
AI
This is still in the development stage and has no valid evidence is present. But the usage of AI as a supporting factor in the human decision-making process has helped in a lot of other domains around the world. We believe that adding AI to the medical domain could prove a huge benefit to the doctor and as well as patient.

IoT

The Internet of things is already proved as a beneficial system for most devices of the world. Examples include CCTV camera vision is transmitted over the cloud to the user's phone. Applying a similar concept of transmitting useful information from a monitoring component of the product to the mobile application, it has created more demand to provide better UX and UI to the user. We have received positive feedback from various users stating that this system is easy to use and easier to interpret the situation of the patient

Bio-Logical Signal processing:
link of Research Paper: https://pubmed.ncbi.nlm.nih.gov/25854665/
Embedded Electronics:
Product Demo Link: 
1.https://www.youtube.com/watch?v=9hkFVxXQlDs,
2.https://www.youtube.com/watch?v=_lcw2WtRuK0&t=2s

Most of the deliveries conducted by staff nurses in low resources healthcare settings which lacks of continuous labor monitoring devices and skilled staff in maternity ward. In current practices, staff nurses measure the FHR by stethoscope/fetoscope/fetal Doppler and take decision of any intervention/referral in case FHR goes beyond threshold value. They do not consider FHR & uterine contraction together that leads to delay in early detection of fetal distress and further leads to delay in early referral to higher health facility. An affordable & easy to use labor monitoring device for early detection of fetal distress for low resources healthcare settings has a potential to prevent neonatal mortality & morbidity. In low resources healthcare settings where cesarean facility is not available, the early detection of fetal distress will help low skilled health workers in early decision for referral to higher health facility. In India, we have only 40,000 OBGYN specialist over 25 Million births per year. Empowering the staff nurses in a very cost effective manner for continuous labor monitoring and early detection of fetal distress will be a breakthrough. In this scenario, affordable and easy to use innovations which can empower the midwives/staff nurses in assisting delivery/monitoring/referral/early decision making will definitely make impact in reducing the MMR and IMR.

Till now, more than 30,000 pregnant women monitored during intrapartum period from our solutions. In next one year, we expect to serve 200,000 pregnant women. In next five years, we expect to serve 3 million pregnant women during intrapartum period.

We plan to reach out to private hospitals through existing OBGYN medical device suppliers, as they already have established networks with the hospital. We plan to reach out to government hospitals through government and non for profit organisations. We will work on both the strategies together to deploy solutions in at least 500 hospitals to have an impact on 200,000 pregnant women during intra-partum period by the end of 2021. We aim to reach out to minimum 2500 government healthcare settings & 2500 private healthcare settings by the end of 2025 to have an impact on minimum 3 Million pregnant women. We will mainly focus on low and middle income countries where our solution need the most.

1. Country wise medical device regulation is one of major barrier which will prevent/delay us to enter in the other geography in next 5 years. 

2. Another major barrier is the geography wise language which we need to incorporate into device and mobile application.  

3.Another barrier is the financial constrained to start the pilot in another countries. 

4. Every time, the hospitals in another countries ask for the clinical validation and do not accept the validation done in India, that also delay the process. 

5. At the moment, we are scaling up in India and have adequate certificate and regulatory approval for scaling up in India. However, health is a state subject in India and every state takes its own time and decision to scale up in the respective state.

1. We have already identified the regulatory requirements of our upcoming countries and started working on it with the local organisation. 

2. To make the smoothened process, we do the pilot with 1 local hospital/medical college to make sure we adhere to all their norms and language, so it can be scaled up.

3. We are figuring out the local maternal and child health related non for profit organisations for the partnership and funding

4. We go through the small clinical pilot with proper ethical approval, so this data can be used by the distributor/partner as well for the scaling up in the respective countries.

5. We are partnering with the local state with organisations who closely work with the state government to make sure the fasten adoption.

Full Time Staff - 22

Part Time Staff - 2

Contractors - 2

Our team includes mix of social entrepreneur, hardware engineers, software engineers, testing engineers, product design engineers, clinical research specialist and business development people. Every department (hardware, software, clinical research, design, business development) have a lead who is having 3+ experience in medical device industry and passionate for impact. Our medical advisors are having 25+ years experience as an OBGYN. Our business advisors are having 20+ years experience in scaling up the medical products.

1. WISH Foundation is a non for profit organization based in North India and closely word with 4 state government on healthcare programs. We have partnered with them for the pilot in government hospitals in these states. We have already conducted pilots in 10+ hospitals with them.

2. Karuna Trust is a non for profit organization based in South and East India. They work with 3 state government on various healthcare programs. We have partnered with them for the pilot in government hospitals in these states. We have already conducted pilot in 15+ hospitals with them.

3. VILLGRO is a non for profit organization based in South India. They are a social startup incubation organization and provide funding/mentor support to social startups. They have a very large network in the social space. We are incubated with VILLGRO.

4. SELCO Foundation is a non for profit organization based in South India. They have programs into solar panel based healthcare facilities and we have partnered with them to conduct pilot in 10+ hospitals with them.

5. We have partnered with Karnataka health department and conducted pilot with them in 70+ hospitals in Karnataka state. 

Our customers are OBGYNs/nursing home/maternity hospitals/government hospitals/private hospitals who conduct deliveries. We sell the device and mobile application to the hospitals as a one time cost. Further, we sell the disposable electrode which bring the recurring revenue to us. The disposable electrode is for per patient. The hospital includes the monitoring charges and disposable electrode charges in the overall intrapartum services provided to the patient. The device and disposable electrode cost is much affordable and easy to use to the hospital and patient than the existing products available in market. More than 50% of the hospitals even do not have such kind of monitoring device because of the affordability. We did partnership with local distributors and NGO to make sure our device reaches to these hospitals, hence we can make the impact.

Global fetal monitoring market was valued at $2,206 million in 2015, and is expected to reach $3,584 million in 2022, registering a CAGR of 7.1% from 2016 to 2022. In India, every year 27 million deliveries take place across 1,50,000 sub-centers, 27000 PHCs (Primary healthcare centers), 5000 CHCs (Community healthcare centers), 700 District hospitals and 1,00,000 private maternity hospitals. Serviceable Available Market (SAM) will be $ 2 million by 2021 and $5 million by 2023 in India. We will sell minimum 500 devices ($ 1 million USD revenue) to OBGYN Department of the hospitals in India by the end of 2021. We aim to reach out to minimum 2500 government healthcare settings & 2500 private healthcare settings ($ 15 million USD) by the end of 2025. Further, we are planning to apply for transition to scale grants like Saving Life at Birth, Grand Challenges Canada. We have also raised seed capital from impact investors.